From the Guidelines
Glimepiride is not recommended during pregnancy due to its potential to cause neonatal hypoglycemia and other complications, and insulin therapy should be initiated instead. Glimepiride, a sulfonylurea, crosses the placenta and may cause prolonged and severe hypoglycemia in the newborn, as well as other complications such as macrosomia and increased neonatal abdominal circumference 1. The use of sulfonylureas, including glimepiride, has been associated with a higher rate of neonatal hypoglycemia, macrosomia, and increased neonatal abdominal circumference compared to insulin or metformin 1.
Key Considerations
- Glimepiride crosses the placenta and may cause harm to the developing fetus
- Insulin therapy is the preferred treatment for gestational diabetes mellitus (GDM) due to its ability to provide effective glucose control without crossing the placenta in significant amounts 1
- Oral hypoglycemic agents, including glimepiride, should not be used as first-line agents for treating hyperglycemia in GDM due to the lack of long-term safety data 1
Recommendations
- If you are currently taking glimepiride and planning pregnancy, consult your healthcare provider to transition to insulin before conception
- If you discover you're pregnant while taking glimepiride, contact your doctor immediately to switch to insulin therapy
- Insulin therapy should be initiated as soon as possible to minimize the risks associated with glimepiride use during pregnancy 1
From the FDA Drug Label
- 1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia.
Fetal/neonatal adverse reactions Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age Prolonged severe hypoglycemia, lasting 4–10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life.
Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glimepiride tablets should be discontinued at least two weeks before expected delivery
The effects of Glimepiride on pregnancy include:
- Neonatal adverse reactions: such as hypoglycemia, respiratory distress, birth injury, and being large for gestational age
- Prolonged severe hypoglycemia in neonates born to mothers receiving glimepiride at the time of delivery
- Fetotoxicity was observed in animal studies at doses 50 times and 0.1 times the maximum human dose, respectively
- Discontinuation of glimepiride is recommended at least two weeks before expected delivery to minimize the risk of neonatal hypoglycemia 2
From the Research
Effects of Glimepiride on Pregnancy
There are no research papers to assist in answering this question, as the provided studies do not mention Glimepiride (also known as Glimipiride) specifically.
Alternative Medications
However, the studies do discuss the effects of other oral hypoglycemic agents, such as glyburide and metformin, on pregnancy:
- Glyburide has been associated with increased neonatal hypoglycemia 3 and macrosomia 4.
- Metformin has been associated with less maternal weight gain, but recent studies have shown a trend toward increased weight in offspring exposed to metformin in utero 3.
- Both glyburide and metformin cross the placenta and may be used as alternatives to insulin in the treatment of gestational diabetes mellitus (GDM) 5, 6, 7.
- The use of glyburide and metformin in GDM has been shown to be safe and effective, but further studies are needed to assess long-term maternal and fetal outcomes 5, 6, 3, 7.
Key Considerations
Some key considerations when using oral hypoglycemic agents in pregnancy include: